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Downstream Process Development Associate Scientist II

2 months ago

King of Prussia, Pennsylvania, United States SK pharmteco Full time
Job Summary

SK Pharmteco is seeking a highly skilled and experienced Downstream Process Development Associate Scientist II to join our team. As a key member of our process development team, you will be responsible for supporting the downstream process development technology transfer activities for viral vector pilot and GMP manufacturing campaigns.

Key Responsibilities
  • Process Development Support: Work closely with process development scientists and clients to transfer process knowledge to scale-up processes for pilot-scale manufacturing campaigns.
  • Process Fit to Plant Evaluation: Support the evaluation of process fit to plant for downstream process development.
  • Protocol Development: Author protocols to support pilot-scale manufacturing campaigns.
  • Independent Execution: As an Associate Scientist II, some degree of independent execution is expected.
  • Planning and Logistics Support: Provide planning and logistics support for pilot-scale execution.
  • Technical Support: Provide hands-on and technical support during execution of pilot-scale manufacturing campaigns.
  • Knowledge Transfer Documentation: Author knowledge transfer documentation for GMP manufacture, including bill of materials, process flow diagrams, and sample plans.
  • Batch Record Development: Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
  • Technology Transfer Planning: Collaborate with process development scientists and manufacturing to establish technology transfer plans and perform technical risk assessments for product/process introduction to the GMP facility.
  • Technical Support for Process-Related Issues: Provide technical support for process-related issues or investigations.
  • Scientific/Engineering Support: Provide scientific/engineering support for technology transfer and manufacturing of viral vectors.
Requirements
  • Education: B.S. in engineering, life sciences, or related field, plus 1-3 years in relevant academic or industry technical experience.
  • Experience: M.S. in engineering, life sciences, or related field, plus 1-2 years in relevant academic or industry technical experience.
  • Hands-on Experience: Hands-on experience with common downstream pilot equipment and operations, including depth filtration, Akta process, ultracentrifugation, UF/DF, etc., and ability to train junior staff.
  • Attention to Detail: Ability to follow procedures with attention to detail and successfully execute experiments at the bench.
  • Comfort in a Fast-Paced Environment: Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Data Analysis: Demonstrated ability to maintain detailed execution records and perform data analysis.
  • Gene Therapy Manufacturing Experience: Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred.
  • Communication and Teamwork Skills: Strong communication skills (e.g., clear and concise) and a team player.
  • Time and Project Management Skills: Strong time and project management skills.
  • Critical Thinking: Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
  • Self-Motivation and Flexibility: Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
  • Ownership of Projects: Takes ownership of assigned projects, consulting with management and peers.
  • Data Interpretation: Able to understand and interpret data/information and its practical application.
Physical Requirements
  • Prolonged Sitting and Computer Work: Prolonged periods of sitting at a desk and working on a computer.
  • Lifting and Standing: Must be able to lift up to 30 pounds at times and stand/ work in a lab setting for more than 4 hours when needed.